MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED CRYSTALENS ACCOMMODATING IOL; LENS, INTRAOCULAR, ACCOMMODATIVE

Model Number AT50AO

Device Problem Malposition of Device (2616)

Patient Problem Blurred Vision (2137)

Event Date 06/11/2015

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that approximately 1 month post lens implant the patient noted blurred vision.The lens vaulted (z-syndrome).Posterior capsular opacification (pco) was also observed.A yag was performed but was unsuccessful.The reason for yag was not provided.The lens was subsequently repositioned.The patient's current prognosis and treatment were described as "good, adjust glaucoma drops".

Manufacturer Narrative

The lens remained implanted.One retain sample from the same lot (022096) was dimensionally inspected and all measurements were found to be within specifications.The device history records were reviewed and there were no discrepancies or unusual finding that relate to the reported issue.Based on the information available, the root cause of the reported event could not be conclusively determined.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Type of Device: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 10574 acacia street suite d1; rancho cucamonga CA 91730
• Manufacturer Contact: sharon spencer ; 50 technology drive; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5099284
• MDR Text Key: 26593015
• Report Number: 0001313525-2015-02629
• Device Sequence Number: 1
• Product Code: NAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2017
• Device Model Number: AT50AO
• Device Lot Number: 022096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR